SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.
SetPoint Medical is seeking experienced quality engineers to work collaboratively in a cross-functional environment to ensure processes are implemented in a manner consistent with the Quality Management System. The Quality Engineers will be responsible for championing corrective and preventive actions through the lifecycle, from request approval to checking effectiveness, and for the control of equipment and automated software.
- Generate and process Corrective Action Requests (CAR) and Preventive Action Requests (PAR) from Quality Management System outputs
- Champion CAPAs through the stages of Investigation, Action Plan, Implementation, and Effectiveness
- Report progress tracking of CAPAs against planned dates
- Manage Control of Equipment process
- Define requirements, write verification/validation test plans, execute testing, write test reports, and oversee calibration/maintenance
- Report compliance status of Equipment
- Manage Automated Software Validation process
- Define intended use and requirements, write validation plans with test scripts, execute validation testing, write test reports, and perform ongoing re-validation monitoring
- Report status of Automated Software Validation activities
- Other projects as assigned
- Bachelor's degree in Engineering, related technology, or equivalent experience required; MS preferred
- Regulated Quality Management System experience of 3 or more years required
- Experience with Class III implantable device Quality Management Systems strongly preferred
- Demonstrated individual and team-based contributions towards maintaining a Quality Management System
- Current working knowledge of 21 CFR Part 820 (QSR), ISO 13485, ISO 14971, and other standards as required
- Demonstrated skill in statistical analysis
Required Skills and Abilities
- Ability to work collaboratively and effectively on cross-functional teams to meet development project goals
- Ability to effectively support multiple high priority deliverables at once
- Outstanding written and oral communication skills
- High attention to detail
- Ability to review, analyze, summarize, and interpret data to draw conclusions and make appropriate recommendations and decisions
- Must be able to write clear, understandable written reports, and give oral presentations
- Strong organizational and time management skills
- Ability to take a creative and proactive approach when considering resolutions and/or alternatives
- Effective interpersonal/communication skills
- Approximately 15% travel may be necessary
Company Headquarters in Valencia, CA.
Please address all inquiries to email@example.com.